19796 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations 

pressure indicator at the end of the 

discharge line to confirm that the 

container has not discharged. 

(2) The discharge line terminates 

inside the airplane. As part of a predeparture check, visually inspect the 

pressure indicator for the container for 

loss of pressure within the container. 

(b) The certificate holder also must 

ensure that only non-corrosive 

extinguishing agents are used in systems 

where the pressure discharge line 

terminates inside the airplane. 

PART 135—OPERATING 

REQUIREMENTS: COMMUTER AND 

ON DEMAND OPERATIONS AND 

RULES GOVERNING PERSONS ON 

BOARD SUCH AIRCRAFT 

■ 3. The authority citation for part 135 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 41706, 44113, 

44101, 44701–44702, 44705, 44709, 44711–

44713, 44715–44717, 44722. 

■ 4. Amend § 135.169 by revising 

paragraph (a) to read as follows: 

§ 135.169 Additional airworthiness 

requirements. 

(a) Except for commuter category 

airplanes, no person may operate a large 

airplane unless it meets the additional 

airworthiness requirements of 

§§ 121.215 through 121.283 and 121.307 

of this chapter. 

* * * * * 

Marion C. Blakey, 

Administrator. 

[FR Doc. 07–1937 Filed 4–19–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Clindamycin Solution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an abbreviated new animal 

drug application (ANADA) filed by First 

Priority, Inc. The ANADA provides for 

the veterinary prescription use of 

clindamycin hydrochloride oral 

solution in dogs and cats for the 

treatment of various infections due to 

susceptible bacterial pathogens. 

DATES: This rule is effective April 20, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: First 

Priority, Inc., 1585 Todd Farm Dr., 

Elgin, IL 60123, filed ANADA 200–398 

for the veterinary prescription use of 

Clindamycin Hydrochloride Oral Drops 

in dogs and cats for the treatment of 

various infections due to susceptible 

bacterial pathogens. First Priority, Inc.’s 

Clindamycin Hydrochloride Oral Drops 

is approved as a generic copy of 

ANTIROBE AQUADROPS Liquid, 

sponsored by Pharmacia & Upjohn Co., 

a Division of Pfizer, Inc., under NADA 

135–940. The ANADA is approved as of 

March 19, 2007, and 21 CFR 520.447 is 

amended to reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

FDA has determined under 21 CFR 

25.33(a)(1) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 520.447 revise paragraph (b) to 

read as follows: 

§ 520.447 Clindamycin Solution. 

* * * * * 

(b) Sponsors. See Nos. 000009, 

051311, 058829, and 059130 in 

§ 510.600(c) of this chapter. 

* * * * * 

Dated: April 9, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–7472 Filed 4–19–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Oral Dosage Form New Animal Drugs; 

Dexmedetomidine; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending a 

final rule that appeared in the Federal 

Register of January 4, 2007 (72 FR 263), 

revising the animal drug regulations to 

reflect approval of an original new 

animal drug application (NADA). The 

document incorrectly listed the amount 

of drug per milliliter of 

dexmedetomidine hydrochloride 

injectable solution. This action is being 

taken to improve the accuracy of the 

regulations. 

DATES: This rule is effective April 20, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–267–9019, 

e-mail: george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA has 

discovered that an error has been 

incorporated into the agency’s 

regulations for 21 CFR part 522. This 

document corrects that error. 

Publication of this document constitutes 

final action under the Administrative 

Procedure Act (5 U.S.C. 553). FDA has 

determined that notice and public 

comment are unnecessary because this 

amendment is nonsubstantive. 

List of Subjects in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 


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